SUPPLY CHAIN ARTICLES
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![US flag and European union-GettyImages-2226674966]( "Can America's Retreat On mRNA Be Europe's Opportunity?")
Can America's Retreat On mRNA Be Europe's Opportunity?With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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![GettyImages-512732746]( "Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned")
Moderna & The Global mRNA Supply Chain: Regulatory Lessons LearnedOne of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.
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![Helping Hand-GettyImages-1314188794]( "Multidisciplinary mRNA: What Can We Learn From Other CGTs?")
Multidisciplinary mRNA: What Can We Learn From Other CGTs?Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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![GettyImages-1335381149]( "mRNA Vaccines: Key Considerations For Development & Manufacturing")
mRNA Vaccines: Key Considerations For Development & ManufacturingAs we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
SUPPLY CHAIN VIDEOS
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Quality-GettyImages-1360733079]( "Understanding The Hidden Value Of Quality")
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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![Supply Chain Management GettyImages-1304746031]( "Uninterrupted Supply To Meet Demand")
Explore a solution for biopharmaceutical companies concerned about the risks an increase in campaign volume can pose to their production timeline.
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![iStock-1222894162-vaccine-lab-PPE]( "mRNA Vaccine Development: Planning, Workflow, Supply Chain Success")
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
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![GettyImages-1409734937 RNA polymerase]( "RNA Polymerases For Efficient mRNA Manufacturing")
Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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![Merck Building-shmear]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Building Stability Through Integrated Cryopreservation")
Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.
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![GettyImages- 1180547354 trial data]( "Understanding CRISPR Clinical Trials: Your Questions Answered")
CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
